Ministry of Health: medical cannabis circulation in Ukraine will be transparent and 100% traceable
On August 16, the Law regulating the circulation of cannabis plants for medical, industrial, scientific, and technical purposes comes into force. To implement the Law, the Ministry of Health team, together with the Ministry of Agrarian Policy, the State Service of Ukraine on Medicines and Drugs Control, the Ministry of Internal Affairs, the National Police and other executive authorities, has developed bylaws that regulate all processes in detail and allow patients to receive medicines made from medical cannabis.
The most important change that has been implemented is that cannabis is now allowed for medical purposes. Cannabis, its resin, extracts, and tinctures have been excluded from the list of particularly dangerous substances. Previously, their circulation was prohibited - now it is allowed but with certain restrictions. It should be recalled that the Law specifies the content of tetrahydrocannabinol (THC) in dried medical cannabis straw, which must be equal to or greater than 0.3%.
To ensure the cultivation of medical cannabis in Ukraine, the Licensing Regulations have been developed and will soon be considered by the Cabinet of Ministers. Also, the entire chain of medical cannabis circulation, from import or cultivation to dispensing to a patient in a pharmacy, will be subject to licensing control.
The requirements for the cultivation of cannabis plants include cultivation in closed ground conditions; ensuring round-the-clock video surveillance with free access to it for the National Police; and compliance with good practices for the cultivation and harvesting of raw materials of plant origin (GACP).
For cultivation, there is a procedure for purchasing plant seeds - they must have a quality certificate and be registered in the State Register of Plant Varieties Suitable for Distribution in Ukraine.
Laboratory tests of medical cannabis for THC content will be carried out exclusively in state laboratories, and plant samples will be taken with the participation of the National Police, which will ensure clear state control over the prevention of drug trafficking.
Additional elements of state control over drug trafficking include state security escorting the transportation of medical cannabis and medicines made from it.
The transparency and control of the circulation of medical cannabis medicines will be ensured by an electronic system, which has already been regulated by law and will be launched this autumn after technical developments.
Every medical cannabis transaction must be registered in the electronic system within the day after it is made. More than 30 types of transactions will be recorded and accounted for about more than 10 objects of accounting. The system will include information on the production of medical cannabis seeds, sowing, cloning, planting, sending samples for laboratory testing, harvesting plants, transportation, purchase, manufacturing of medicines, waste disposal, dispensing in a pharmacy, etc. Seeds, planting material, plants, internal pharmacy preparations, medicines, waste, etc. will be subject to accounting.
It is also allowed to import cannabis plant substance, which can be used to make medicines in a pharmacy. In order to import raw materials into Ukraine, a licensed importer must obtain an appropriate permit from the State Service of Ukraine on Medicines and Drugs Control, and not exceed the quotas established by the state. The substance will be registered as an active pharmaceutical ingredient (API) in the State Register of Medicines within a shortened timeframe (up to 30 days).
Medicinal cannabis products will be manufactured in a pharmacy and prescribed by prescription to patients for whom conventional medicines have no therapeutic effect or cause adverse reactions that are poorly tolerated.
It will be possible to purchase such medicines in Ukraine only with an electronic prescription, which will specify the dosage form and dosage, and names of the active ingredients that make up their composition. It is expected that medical cannabis products will be available to patients in the form of oral drops, hard capsules, and dental pastes.
The law allows people entering or leaving Ukraine or transiting through its territory to carry cannabis-based medicines for their own use in an amount not exceeding the specified one in a doctor’s prescription.
It should be recalled that the law refers only to the medical, not recreational use of cannabis-based medicines.
To simplify the work of market participants, the Ministry of Health holds regular meetings with stakeholders and explains how the main mechanisms of medical cannabis circulation will work.